Postoperative Concurrent Chemoradiotherapy Combined With Endostar for High-risk Early Stage Cervical Cancer (ChESS)
Postoperative Concurrent Chemoradiotherapy Combined With Recombinant Human Endostatin for High-risk Early Stage Cervical Cancer: A Phase II Pilot Study (ChESS).
研究概览
详细说明
This is a pilot phase 2, single arm study to assess the efficacy and safety of concurrent chemoradiotherapy combined with recombinant human endostatin (Endostar) in early stage cervical cancer patients with high risk factor(s).
Postoperative pelvic radiotherapy starts 2-3 weeks after surgery. Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total prescription dose of 45-50Gy to PTV region. The external beam radiotherapy should be completed within 6 weeks. Concurrent chemotherapy consists of cisplatin (75 mg/m2, day 1-3) and 5-fluorouracil (5-FU; 1000mg/m2/day, civ, day 1-4) for 2 cycles every 3 weeks. Recombinant human endostatin (Endostar,15mg/m2/d, civ, d1-7) is applied 3 days before the concurrent chemoradiotherapy for 2 cycles every 3 weeks.
Aimed to recruit total of 120 cases in this single arm study. The primary endpoint is 3-year disease-free survival and acute toxicity. Secondary endpoints include time to distant metastasis survival, local-regional recurrence free survival, 3 and 5-year overall survival, and safety and tolerability. Quality of life will be evaluated with EORTC-Q30.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Ke Gu, M.D., Ph.D
- 电话号码:86-13405070898
- 邮箱:dr.guke@hotmail.com
研究联系人备份
- 姓名:Zhiliang Ding, M.D.
- 电话号码:86-18913535515
学习地点
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Jiangsu
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Suzhou、Jiangsu、中国、215001
- 招聘中
- The Affiliated Suzhou Hospital of Nanjing Medical University
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接触:
- Ke Gu, M.D., Ph.D
- 电话号码:86-13405070898
- 邮箱:dr.guke@hotmail.com
-
接触:
- Zhiliang Ding, M.D.
- 电话号码:86-18913535515
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged between 18 and 70 years.
- Histologically confirmed adenocarcinoma or squamous cervical carcinomas.
- Chest CT scan and ultrasound must be done prior to surgery as to rule out distant metastasis.
- Operable patients with clinical diagnosis of FIGO stage IB-IIA cervical cancer.
- Complete radical hysterectomy of cervical cancer is mandatory. All gross diseases must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor. Para-aortic lymph node sampling is performed according to gynaecologist decision.
- Patients with one of these risk factors:positive pelvic nodes, parametrial invasion, positive surgical margin.OR patients with at least two of following risk factors: tumor size≥4cm,lymphovascular space invasion,stromal invasion≥1/2.
- Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group).
- Adequate organ function is needed, including cardio-respiratory, hepato-renal and hematological reserves: Absolute neutrophil count (ANC)≥1.5×109/L;Platelet count≥100×109/L; ASAT&ALST<1.5 times upper limit of normal (ULN) (With hepatic metastases, ASAT&ALST<5.0 times upper limit of normal);Bilirubin <1.5 times ULN;Creatinine≤1.25×ULN or Creatinine clearance≥50 mL/min.
- Signed written informed consent prior to study entry.
Exclusion Criteria:
- Previous radiation or chemotherapy treatment or major pelvic surgery.
- Patients with distant metastasis confirmed by imaging or pathology.
- Other uncured malignant tumors in the past five years, except the cured skin basal cell carcinoma and breast carcinoma in situ.
- Any prior anticancer therapy.
- Unable to tolerate postoperative concurrent chemoradiotherapy.
- Patients with evidence of being allergic to fluorouracil, cisplatin or Endostar.
- Patients with serious comorbidity that might potentially influence the practice of protocol, including severe infection, myocardial infarction, severe arrhythmia, severe cerebrovascular disease, severe mental disorder, etc.
- Patients with Heart related adverse events or thrombotic events in the past 6 months.
- Patients with hepatitis B, hepatitis C and human immunodeficiency virus (HIV) or any other active viral infections.
- Participate in other clinical researchers.
- The estimated survival<3 months;
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Chemoradiotherapy + Endostar
Chemoradiotherapy with Endostar:
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Chemoradiotherapy with Endostar:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
3-year Disease-free survival
大体时间:3 years
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From date of surgery until the date of first documented local-regional progression or distant metastasis (determined by CT or MRI scan and/or biopsy) or death (from any cause) assessed up to three years.
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3 years
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Acute toxicity
大体时间:3 months
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Evaluate the treatment induced toxicity according to CTCAE 4.0 during the time of chemoradiotherapy and Endostar which starts from the first day of Endostar and lasts three months.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Time to distant metastasis survival
大体时间:3 years
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Determine the non-distant metastasis survival in early-stage cervical cancer patients with high risk factors, defined as time from the date of surgery to first distant metastasis event (determined by CT or MRI scan and/or pathologic disease on biopsy).
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3 years
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Local-regional recurrence free survival
大体时间:3 years
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Determine the local-regional recurrence free survival in early-stage cervical cancer patients with high risk factors, defined as time from the date of surgery to first local-regional recurrence event (determined by CT or MRI scan and/or pathologic disease on biopsy).
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3 years
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3-year overall survival rate
大体时间:3 years
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Determine the 3-year overall survival rate in early-stage cervical cancer patients with high risk factors, defined as time from the date of surgery to death of all cause at time of 3 years after operation.
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3 years
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5-year overall survival rate
大体时间:5 years
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Determine the 5-year overall survival rate in early-stage cervical cancer patients with high risk factors, defined as time from the date of surgery to death of all cause at time of 5 years after operation.
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5 years
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Quality of Life (QoL)
大体时间:3 years
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Collect QoL data on early-stage cervical cancer patients with high risk factors.
The data is measured by EORTC QLQ-C30 (Version 3.0) according to investigator collection at the starting and ending time of the adjuvant treatment.
EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
The core and disease-specific for cervix modules are selected to estimate treatment related influence on patients' life.
The final score of the questionnaire is collected and analyzed according to detailed scoring procedures from manuals.
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3 years
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合作者和调查者
调查人员
- 首席研究员:Ke Gu, M.D., Ph.D、The Affiliated Suzhou Hospital of Nanjing Medical University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Chemoradiotherapy+ Endostar的临床试验
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Simcere Pharmaceutical Co., LtdThe Affiliated Changzhou Tumor Hospital of Suzhou University未知
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Shanghai Chest HospitalWuhan University尚未招聘